Safety and Efficacy Study of LX102-C01 Treatment of Neovascular Age-Related Macular Degeneration (nAMD)

Neovascular Age-related Macular Degeneration Clinical Trial

Official title:

An Open Label Dose Escalation Clinical Trial to Evaluate the Safety and the Efficacy of LX102-C01 in Patients With Neovascular Age-Related Macular Degeneration (nAMD)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05831007
• Other study ID #: SHGH-LX102-C01
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 6, 2021
• Est. completion date: June 2024

Study information

• Verified date: April 2023
• Source: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this study is to evaluate the safety and efficacy of LX102-C01 treatment of nAMD. This study will enroll subjects aged ≥ 50 years old to receive a single unilateral intravitreal (IVT) injection of LX102-C01 to evaluate its safety and efficacy.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 6
• Est. completion date: June 2024
• Est. primary completion date: June 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

1. Willing to sign the informed consent, and willing to attend follow-up visits.

1. Age = 50

2. Diagnosis of active CNV secondary to neovascular AMD

3. The study eye must have a best-corrected E-ETDRS visual acuity letter score of less than or equal to 63.

4. Subjects must have received a minimum of 2 injections within 6 months prior to screening.

5. Demonstrated a meaningful response to anti-VEGF therapy

Exclusion Criteria:

1. CNV or macular edema in the study eye secondary to diseases other than nAMD

2. Retinal detachment, uveitis, uncontrolled glaucoma in the study eye, or any condition preventing visual acuity improvement

3. Acute coronary syndrome, myocardial infarction or coronary artery revascularization, CVA, TIA in the last 6 months

4. Uncontrolled hypertension defined as average SBP =160 mmHg or an average DBP =100 mmHg

5. Uncontrolled diabetes defined as HbA1c >7.5%

Related Conditions & MeSH terms

• Macular Degeneration
• Neovascular Age-related Macular Degeneration
• Wet Macular Degeneration

Intervention

Genetic:
• LX102-C01 Injection
Qualified subjects will receive a single unilateral intravitreal injection of LX102-C01 at Day 0 in the trial.

Locations

Country	Name	City	State
China	Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine	Innostellar Biotherapeutics

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of adverse events (AEs)	Incidence of adverse events (AEs) within 52 weeks of LX102-C01 intravitreal injection at different doses	52 weeks
Primary	Incidence of serious adverse events (SAEs)	Incidence of serious adverse events (SAEs) within 52 weeks of LX102-C01 intravitreal injection at different doses	52 weeks
Secondary	Mean change in BCVA from Baseline	BCVA measured by ETDRS	24 weeks, 52weeks
Secondary	Mean change in Central Subfield Thickness (CST) from Baseline	To evaluate the effect of LX102-C01 on CST	24 weeks, 52 weeks
Secondary	Mean number of anti-VEGF injections over time	Mean number of anti-VEGF injections over time	52 weeks
Secondary	Change of quality of life scores (VFQ-25) from Baseline	Changes of VFQ-25 questionaire from Baseline to 52 weeks	52 weeks